Millions of people suffer from progressive gastroesophageal reflux disease (GERD) which is characterized by frequent episodes of heartburn, typically on at least a daily basis. Without adequate treatment, GERD can cause erosion of the esophageal lining as the lower esophageal sphincter (LES), a segment of smooth muscle located at the junction of the stomach and the esophagus, gradually loses its ability to function as the barrier that prevents stomach acid reflux. Chronic GERD can also cause metaplasia to the inner lining of the esophagus where the normal squamous mucosa changes to columnar mucosa, also known as Barrett's esophagus. Barrett's esophagus can progress to esophageal cancer if left untreated.
Endoscopic treatment of Barrett's esophagus includes endoscopic mucosal resection (EMR). One method of performing EMR involves ablation of the mucosal surface by heating the surface until the surface layer is no longer viable. The dead tissue is then removed.
Treatment devices for performing EMR have been developed using bipolar ablation technology that includes circumferentially oriented electrodes to endoscopically ablate the diseased tissue. Typically, the circumferentially oriented electrodes are positioned on an inflatable balloon. The balloon must be inflated to a predetermined size to achieve adequate contact with the diseased tissue for delivery of the appropriate amount of energy from the bipolar ablation device to ablate the diseased tissue. In order to determine the correct size and balloon pressure to achieve adequate ablation, a sizing balloon must first be introduced into the esophagus. Once the proper measurements are made with the sizing balloon, the treatment device can then be endoscopically inserted into the patient's esophagus. The balloon inflated treatment device and procedure requires an additional step to size the balloon and adds more time and potential patient discomfort to the treatment procedure. In addition, the inflated balloon is positioned in front of the endoscope viewing window, preventing direct visualization of the target tissue and potentially leading to ablation of healthy tissue or incomplete ablation of diseased tissue.
What is needed in the art is an ablation treatment device that is simple to use, that minimizes the number of steps in a treatment procedure and that provides treatment under direct endoscopic visualization.